- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951014
Text for Prenatal Health Study
November 13, 2014 updated by: Cornell University
Currently little is known about the health beliefs and behaviors of pregnant adolescents.
The goal of this pilot study is to educate pregnant adolescents via social media about nutrition and fitness during pregnancy and to evaluate their health beliefs and behaviors before and after receiving this information.
Data collected will provide new information on which to base subsequent research and can be used to inform nutritional guidelines or public health programming for this vulnerable age group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this pilot study is to find out if receiving electronic health information (e.g. text messages and Facebook posts) during pregnancy changes how pregnant teens think about their prenatal health and if fetal and maternal health outcomes can be improved. This study aims to:
- Assess the impact of providing health information to pregnant adolescents (through Facebook and text messages) on fetal and maternal health outcomes across pregnancy.
- Assess maternal nutrition knowledge using a brief questionnaire before and after the social media intervention.
- Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity, and life choices by asking teens to participate in interviews and focus groups.
- Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity and life choices through the perspective of healthcare providers by interviewing allied health workers at the adolescent pregnancy clinic.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Rochester, New York, United States, 14609
- Rochester Adolescent Maternity Program Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking pregnant adolescents who have enrolled in the "Vitamin D Status Impacts Inflammation and Risk of Infections during Pregnancy" study (Clinical Trials ID: NCT01815047) and indicated interest on the consent form to participate in additional studies will be eligible to participate in this study. In order to participate, adolescents will have agreed to be contacted for future studies. Adolescents who are < 18 y, carrying a single fetus and between 12-30 weeks of gestation will be eligible to participate in this study.
- Healthcare providers (> 18) who work at the adolescent maternity clinic and interact with pregnant adolescents will be eligible to participate in this study. This would include nurses, midwives, nutritionists, physicians, and social workers of all ages and genders.
Exclusion Criteria:
- Exclusion criteria for this study include adolescent males and females who are not pregnant and do not speak English. Additionally, adolescents participants will be excluded if they have been diagnosed with eating disorders, malabsorption diseases, HIV infection, and diabetes (criteria outlined in parent study protocol; Clinical Trials ID: NCT01815047)
- Healthcare providers who do not speak English will not be eligible to participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Teen Social Media Education
See description under intervention description
|
Health messages provided via a private Facebook group and cellular text messages will be provided across gestation.
|
NO_INTERVENTION: Healthcare Provider Insights
Healthcare providers providing care to pregnant adolescents will serve as key informants to provide an additional perspective for adolescent health beliefs and behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent health attitudes, beliefs, knowledge and behaviors
Time Frame: Change from baseline in health beliefs and behaviors at 40 weeks
|
Teens will receive text messages from study staff and health information will be posted to a private Facebook group page.
They will be able to interact with one another and discuss further the topics that are posted to their group page or that they have received via text message.
Before they receive any of these messages, they will complete a baseline nutrition knowledge survey and participate in a focus group/interview.
Midway through the study, teens will complete a survey about their digital media usage.
Close to delivery, the teens will complete a second nutrition knowledge survey and participate in a final focus group/interview.
All discussions will be related to diet, physical activity and general behaviors that teens engage in independently for prenatal care.
All interviews and focus groups will be recorded so that transcripts can be made and common themes identified.
|
Change from baseline in health beliefs and behaviors at 40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare provider views
Time Frame: From date of enrollment, up to 40 weeks
|
Healthcare providers will be interviewed individually or in focus groups as key informants in order to gain a different view of pregnant adolescent health behaviors.
Health professionals will complete a short demographic survey and participate in one interview in which they will be asked about general health advice they share with teens and how they perceive pregnant adolescent health behaviors.
All interviews will be recorded so that transcripts can be made and common themes identified.
|
From date of enrollment, up to 40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Corrie Whisner, PhD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
September 16, 2013
First Submitted That Met QC Criteria
September 23, 2013
First Posted (ESTIMATE)
September 26, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 17, 2014
Last Update Submitted That Met QC Criteria
November 13, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB #: 1308004041
- 2012-67012-19815 (OTHER: NIFA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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